Pulse Intravascular Lithotripsy for Coronary Artery Disease With Calcified Vessel Walls
Tests a pulse lithotripsy device in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry title: AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
Key facts
- Where
- Auckland, New ZealandSee the site
Where in New Zealand
- Auckland City HospitalAuckland, New ZealandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amplitude Vascular Systems, Inc.
- Trial code
- NCT07510438
- Record updated
- 2 November 2026
- Original description
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.Read full original descriptionShow less
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease - A First-in-Human (FIH) Study
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment of coronary artery disease.
Inclusion: ≥ 18 years of age; Subjects with native coronary artery disease; Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months; The target lesion must be a single de novo coronary lesion; The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and <100% or Stenosis ≥50% and <70% with evidence of ischemia; Lesion length must not exceed 44 mm.
Exclusion: Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure; Subject has a previous stent in the target vessel implanted within last six months; Any previous stent within 10 mm of the target lesion; Subject has New York Heart Association (NYHA) class III or IV heart failure; Target lesion has a myocardial bridge; Subject has renal failure with serum creatinine >2.5 mg/dL, or chronic dialysis; Unprotected LMCA diameter stenosis >30%; Target vessel is excessively tortuous, defined as the presence of 2 or more bends >90 degrees or 3 or more bends >75 degrees; Evidence of aneurysm in target vessel within 10 mm of the target lesion; Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA; Target lesion is a bifurcation with ostial diameter stenosis ≥30%.